Prolonged Mechanical VentilationDD-SRPRNCT03676998
Diaphragm Dysfunction During Prolonged Mechanical Ventilation
A study testing Measurement of diaphragm function in people with Prolonged Mechanical Ventilation, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The transition to unassisted breathing after invasive ventilation often proves challenging. Persistent ventilator dependence predisposes patients to nosocomial complications and death and increases the economic burden of critical illness. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prolonged Mechanical Ventilation
- What is being tested?
- Measurement of diaphragm function
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteFrance
- Study dates
- 22 Feb 2019to 22 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years old;
- Admission in weaning center;
- Tracheostomy;
- Ventilator dependence as defined by clinical intolerance criteria under spontaneous - breathing (Boles et al. ERJ 2017);
- Oral consent
Who cannot join
- Contre indication to the phrenic nerves stimulation technique (pace maker);
- Impossible liberation from the ventilator (degenerative neuromuscular diseases; high level spinal injury);
- Pregnancy;
- No insurance coverage
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determinants of the Recovery of Diaphragm Dysfunction in Patients With Prolonged Mechanical Ventilation
The transition to unassisted breathing after invasive ventilation often proves challenging. Persistent ventilator dependence predisposes patients to nosocomial complications and death and increases the economic burden of critical illness. Ventilator-dependence results from an imbalance between the load and capacity of the respiratory muscle pump. Patients who fail a trial of spontaneous breathing commonly exhibit excess respiratory loads secondary to weaning-induced pulmonary edema, atelectasis or dynamic hyperinflation. At the same time, many ventilator-dependent patients exhibit striking loss of respiratory pump capacity due to diaphragm dysfunction which predisposes to prolonged ventilator dependence. Diaphragm dysfunction is common in ventilated patients. By prolonging ventilator dependence it may be an important contributor to the poor long-term clinical and functional outcomes of survivors of critical illness. While some main risk factors for diaphragm dysfunction have been already described (diaphragm disuse induced by mechanical ventilation, sepsis, initial severity upon admission), the determinants of recovery of diaphragm dysfunction are unknown, as well it has not been elucidated whether diaphragm function can simply improve after the acute phase of ICU admission. Therefore, the goal of this study is to investigate the time course evolution of diaphragm function in patients exposed to prolonged duration of mechanical ventilation (i.e. in a weaning center) and to determine which factors are associated with an improvement of the diaphragm function leading to a safe mechanical ventilation discontinuation.
Read the detailed description
In this prospective study, all patients admitted to the weaning center of Pitié-Salpêtrière Hospital to undertake a weaning program will be closely followed up to assess twice a week their diaphragm function. Only one experimental group will be constituted. Diaphragm function will be assessed with both 1) the phrenic nerves stimulation technique and 2) diaphragm ultrasound (thickness, thickening fraction). The time course evolution of the diaphragm function over the stay will be investigated and all potential factors involved in the change in diaphragm function will be determined.
- Conditions
- Prolonged Mechanical Ventilation
- Being tested
- Measurement of diaphragm function
- Keywords
- Prolonged weaning, Diaphragm dysfunction, Liberation from mechanical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of diaphragm functionDevice
A bilateral magnetic stimulation induces a non voluntary diaphragm contraction and a drop in airway pressure that is measured.
| Study group | Role | What they receive |
|---|---|---|
| Measurement of diaphragm function | Other | Patients will be followed up from admission to weaning with twice a week a diaphragm function multimodal evaluation (ultrasound, phrenic nerves stimulation technique) Receives: Device: Measurement of diaphragm function |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients successfully liberated from the ventilator
Liberation from the ventilator will be defined after 7 days of spontaneous
Measured: After 7 days of spontaneous breathing
Secondary outcomes (3)
Diaphragm function
Diaphragm function will be defined as pressure generating capacity. In practice, it will be assessed by using the phrenic nerves stimulation technique. A bilateral magnetic stimulation of the phrenic nerves will be done and the drop in endotracheal pressure so generated will be measured (twitch pressure).
Measured: Twice a week, up to 4 weeks
Partial liberation from mechanical ventilation
Partial liberation from ventilation will be defined by spontaneous breathing without the ventilator through closed or opened tracheostomy collar for a period of time between 12 and 24 hours, the rest of the time, patients being under invasive or non invasive mechanical ventilation.
Measured: During hospitalization in Intensive Care Unit (ICU), up to 4 weeks
Proportion of patients with diaphragm dysfunction upon admission and upon discharge
Proportion of patients with diaphragm dysfunction will be the ratio of patients with diaphragm dysfunction over the total number of patients enrolled in the study. Diaphragm dysfunction will be defined as a twitch pressure (endotracheal pressure generated by magnetic stimulation) below 11 cmH2O.
Measured: From date of admission in ICU until the date of hospital discharge in ICU, assessed up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2018
- Study start22 Feb 2019
- Primary completion22 Oct 2024 (estimated)
- Study completion22 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prolonged Mechanical VentilationStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin DRES, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03676998
- Sponsor's protocol ID
- K171101J
- Other IDs
- 2017-A03091-52
- Acronym
- DD-SRPR
- Status last verified
- Mar 2023
- First submitted
- 10 Aug 2018
- Last updated
- 28 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Virolle S, Duceau B, Morawiec E, Fosse Q, Nierat MC, Parfait M, Decavele M, Demoule A, Delemazure J, Dres M. Contribution and evolution of respiratory muscles function in weaning outcome of ventilator-dependent patients. Crit Care. 2024 Dec 18;28(1):421. doi: 10.1186/s13054-024-05172-y.
PubMed 39696360
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determinants of the Recovery of Diaphragm Dysfunction in Patients With Prolonged Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT03676998
- Acronym / sponsor ID
- DD-SRPR / K171101J
- Conditions
- Prolonged Mechanical Ventilation
- Keywords
- Prolonged weaning, Diaphragm dysfunction, Liberation from mechanical
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 22 Feb 2019 (actual)
- Primary completion
- 22 Oct 2024 (estimated)
- Study completion
- 22 Oct 2024 (estimated)
- First posted
- 19 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The transition to unassisted breathing after invasive ventilation often proves challenging. Persistent ventilator dependence predisposes patients to nosocomial complications and death and increases the economic burden of critical illness. Ventilator-dependence results from an imbalance between the load and capacity of the respiratory muscle pump. Patients who fail a trial of spontaneous breathing commonly exhibit excess respiratory loads secondary to weaning-induced pulmonary edema, atelectasis or dynamic hyperinflation. At the same time, many ventilator-dependent patients exhibit striking loss of respiratory pump capacity due to diaphragm dysfunction which predisposes to prolonged ventilator dependence. Diaphragm dysfunction is common in ventilated patients. By prolonging ventilator dependence it may be an important contributor to the poor long-term clinical and functional outcomes of survivors of critical illness. While some main risk factors for diaphragm dysfunction have been already described (diaphragm disuse induced by mechanical ventilation, sepsis, initial severity upon admission), the determinants of recovery of diaphragm dysfunction are unknown, as well it has not been elucidated whether diaphragm function can simply improve after the acute phase of ICU admission. Therefore, the goal of this study is to investigate the time course evolution of diaphragm function in patients exposed to prolonged duration of mechanical ventilation (i.e. in a weaning center) and to determine which factors are associated with an improvement of the diaphragm function leading to a safe mechanical ventilation discontinuation.
Detailed description
In this prospective study, all patients admitted to the weaning center of Pitié-Salpêtrière Hospital to undertake a weaning program will be closely followed up to assess twice a week their diaphragm function. Only one experimental group will be constituted. Diaphragm function will be assessed with both 1) the phrenic nerves stimulation technique and 2) diaphragm ultrasound (thickness, thickening fraction). The time course evolution of the diaphragm function over the stay will be investigated and all potential factors involved in the change in diaphragm function will be determined.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Measurement of diaphragm function | Other | Device: Measurement of diaphragm functionPatients will be followed up from admission to weaning with twice a week a diaphragm function multimodal evaluation (ultrasound, phrenic nerves stimulation technique) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age > 18 years old;
- Admission in weaning center;
- Tracheostomy;
- Ventilator dependence as defined by clinical intolerance criteria under spontaneous - breathing (Boles et al. ERJ 2017);
- Oral consent
Key exclusion criteria (4 listed)
- Contre indication to the phrenic nerves stimulation technique (pace maker);
- Impossible liberation from the ventilator (degenerative neuromuscular diseases; high level spinal injury);
- Pregnancy;
- No insurance coverage
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measurement of diaphragm functionA bilateral magnetic stimulation induces a non voluntary diaphragm contraction and a drop in airway pressure that is measured. | Device | Measurement of diaphragm function |
Primary outcome
Proportion of patients successfully liberated from the ventilator
Time frame: After 7 days of spontaneous breathing
Liberation from the ventilator will be defined after 7 days of spontaneous
3 secondary outcomes
Diaphragm function
Time frame: Twice a week, up to 4 weeks
Partial liberation from mechanical ventilation
Time frame: During hospitalization in Intensive Care Unit (ICU), up to 4 weeks
Proportion of patients with diaphragm dysfunction upon admission and upon discharge
Time frame: From date of admission in ICU until the date of hospital discharge in ICU, assessed up to 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2023.
- Derived from this study: PubMed 39696360Virolle S, Duceau B, Morawiec E, Fosse Q, Nierat MC, Parfait M, Decavele M, Demoule A, Delemazure J, Dres M. Contribution and evolution of respiratory muscles function in weaning outcome of ventilator-dependent patients. Crit Care. 2024 Dec 18;28(1):421. doi: 10.1186/s13054-024-05172-y.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin DRES, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Measurement of diaphragm function in people with Prolonged Mechanical Ventilation, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients successfully liberated from the ventilator (time frame: After 7 days of spontaneous breathing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03676998, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2023.